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Alclometasone dipropionate topical

Presentation

Topical preparations of alclometasone dipropionate

Drugs List

  • alclometasone 0.05% cream
  • Therapeutic Indications

    Uses

    Skin conditions responsive to topical corticosteroids

    For the treatment of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

    Dosage

    Adults

    1 application sparingly to the affected area two to three times a day.

    Children

    See Dosage; Adult.

    Contraindications

    Skin infection

    Precautions and Warnings

    Breastfeeding
    Pregnancy

    Contains cetostearyl alcohol: may cause irritation
    Contains propylene glycol: may cause irritation
    Occlusive dressings can increase the likelihood of systemic absorption
    Adrenal suppression may occur even without occlusion
    Prolonged/excessive use may lead to adrenal suppression
    Discontinue if irritation or sensitisation occur
    Avoid long term continuous therapy
    Advise patient residue on clothing/bedding may cause fire hazard
    Fire hazard: Keep away from naked flames and potential sources of ignition

    Systemic absorption of topical corticosteroids may be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children.

    Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and to exogenous corticosteroid effects than mature patients due to a greater absorption due to a large skin surface area to body weight ratio.

    HPA suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels, and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include a bulging fontanelle, headaches and bilateral papilloedema.

    Pregnancy and Lactation

    Pregnancy

    Use alclometasone dipropionate with caution during pregnancy.

    The manufacturer advises caution if alclometasone dipropionate is used during pregnancy. At the time of writing, safety of topical corticosteroid use during pregnancy has not been established and should only be used if the potential benefit justifies the potential risk to the foetus. It is recommended to avoid using large amounts and for long periods of time if possible.

    Lactation

    Use alclometasone dipropionate with caution during breastfeeding.

    The manufacturer advises caution if alclometasone dipropionate is used during breastfeeding. At the time of writing it is unknown whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Effects on exposed infants are unknown.

    Side Effects

    Acne-like eruptions
    Allergic contact dermatitis
    Cushing's syndrome
    Erythema at application site
    Folliculitis
    Growth retardation (children)
    Hypertrichosis
    Hypopigmentation
    Intracranial hypertension
    Irritation (localised)
    Itching at application site
    Local burning
    Maceration of skin
    Miliaria
    Perioral dermatitis
    Rash
    Secondary infections
    Sensitisation
    Skin atrophy
    Striae
    Superficial vascular dilation
    Suppression of the hypothalamic-pituitary-adrenal axis

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: October 2020

    Reference Sources

    Summary of Product Characteristics: Alclometasone Dipropionate 0.05% w/w cream. Aspire Pharma Ltd. Revised December 2019.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 13 October 2020

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